Non-invasive glucose measurements – database and calibration building (RSP-07)
Aim of the study
Calibration and glucose prediction performance assessment for the WM3.4 prototype, with focus on applicability in clinical and home settings.
Study description
Fortyeight participants completed thirty outpatient study days, each consisting of four measurement sessions performed on both the thenar and wrist sites. An additional twentyfour participants completed two inclinic study days to provide controlled reference conditions. Noninvasive optical measurements from the WM3.4 prototype were paired with capillary glucose reference values to evaluate bodysite performance, collectiondepth requirements, and the feasibility of an outpatient study design for calibration model development.
Conclusions
The study identified the best measurement location (the thenar area of the hand) and demonstrated that reliable calibration and glucose prediction models could be derived from both clinical and real-life measurement settings.
Study registration
For more information, see the study registration on ClinicalTrials.gov (NCT03368209).
Related peer-reviewed publication
Lundsgaard-Nielsen SM, Pors A, Banke SO, Henriksen JE, Hepp DK, Weber A. Critical-depth Raman spectroscopy enables home-use non-invasive glucose monitoring. PLoS One. 2018 May 11;13(5):e0197134. doi: https://doi.org/10.1371/journal.pone.0197134
About the study
Study period: December 2015 to May 2017
Prototype ID: WM3.4 (higher efficiency spectrometer)
Comparator: HemoCue 201RT (BGM); Dexcom G4 (CGM)
Site: Department of Endocrinology, Odense University Hospital, Denmark
No of participants: 72
Profile of participants: Adults with all types of diabetes